........... 26-42 Other Biographical Sketches (Not to exceed four pages for each - See instructions)) ........................ 43-46 Resources ................................................................................................................................................. Research Plan 47-68 Introduction to Revised Application (Not to exceed 3 pages) ......................................................................................................... NtA_ Introduction to Supplemental Application (Not to exceed one page) .............................................................................................. N/A N/A A. Specific Aims ......................................................................... _. .................................................................................... _ 47 B. Background and Significance ................................................... _.................................................................................... I'" N/A__ C. Preliminary Studies/Progress Report/ _. (Items A-D: not to exceed 25 pages*) .._ Phase 1Progress Report (SBIP-JSTTR Phase II ONLY) _ * SBIRJSTTR Phase h Items A-D fimited to 15 pages. D, Research Design and Methods ............................................. _ | ..................................................................................... I N/A_ E. Human Subjects ................................................................................................................................................................. 64-65 Protection of Human Subjects (Required if Item 4 on the Face Page is marked "yes") __ 64 Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes") ................................................................. ___ 65_. Inclusion of Minodties (Required if Item 4 on the Face Page is marked "Yes") ............................................................... 65 Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") ................................................................. 65 Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked '_es" anda Phase 1, II, or III clinical trial is proposed ...................................................................................................................................................... N/A F. Vertebrate Animals ............................................................................................................................................................. __ N/A_ G, Literature Cited ................................................................................................................................................................... ..... 69 H. Consortium/Contractual Arrangements ............................................................................................................................... 70 I. Letters of Support (e,g., Consultants) ................................................................................................................................. j1 -EA__ J. Product Development Plan (SBIP-JSTTR Phase II and Fast-Track ONLY) .......................................................................... N/A Checklist .................................................................................................................................................... 75 Check if Appendix (Five collated sets. No page numbering necessary for Appendix.) Appendix is Included Appendices NOT PERM/TTED for Phase / SB/R/S TTR unless specifically solicited, Number of publications and manuscripts accepted for publication (not to exceed 10) Other items (list): PHS 398 (Rev. 05101) Page 3 Form Page 3